Kornimate/medical-research-clean huggingface dataset:
dds-25 gauge in patients with macular edema secondary to retinal vein occlusion (rvo)

Conditions: Macular Edema; Retinal Vein Occlusion

Summary: this study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone (dds-25) for the treatment of macular edema associated with retinal vein occlusion.

evaluate the effects on visual acuity, electroretinography, fluorescein angiography and optical coherence tomography in 10 patients with macular edema associated with retinal vein occlusion undergoing intravitreal injection of implant of dexamethasone (dds-25).

Eligibility criteria:
inclusion criteria: * 18 years of age or older with macular edema resulting from retinal vein occlusion * decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse) * visual acuity in other eye no worse than 20/200 exclusion criteria: * known anticipated need for ocular surgery within next 12 months * history of glaucoma or current high eye pressure requiring more than 1 medication * diabetic retinopathy * uncontrolled systemic disease * known steroid-responder * use of systemic steroids * use of warfarin/heparin
comparison of clinical effectiveness of full endoscopic lumbar discectomy (feld) and microdiscectomy (md) in patients with lumbar disc herniation

Conditions: Lumbar Degenerative Disease; Lumbar Radiculopathy; Sciatic Leg Pain; Sciatic Nerve Compression; Discopathy; Disc Herniation; Disc Herniation with Radiculopathy

Summary: the goal of this clinical trial is to compare the clinical effectiveness of full endoscopic lumbar discectomy (feld) and microdiscectomy (md) in patients aged 18-85 with single-level lumbar disc herniation who have not undergone prior lumbar surgery. this study also aims to perform a radiological analysis of mri scans before and after treatment to optimize patient selection and surgical strategies. the main questions it aims to answer are: * does feld provide superior early postoperative pain relief (measured by vas) compared to md? * does feld offer better functional recovery (measured by comi and odi scores) postoperatively compared to md? * can radiological analysis of pre- and post-operative mri images help optimize patient qualification and guide surgical strategies? researchers will compare patients undergoing feld to those undergoing md to see if endoscopic techniques result in faster recovery and lower early postoperative pain while maintaining similar long-term outcomes. the study will also analyze how mri findings correlate with clinical outcomes to refine operative decision-making. participants will: * undergo either feld or md surgery * complete vas, comi, and odi questionnaires at pre-specified follow-up intervals (1, 3, 6, and 12 months post-surgery) * have mri scans 24 hours before surgery, 24 hours after surgery, and at each follow-up to assess disc recurrence, residual pathology, and to optimize surgical strategies.


Eligibility criteria:
inclusion criteria: * patients aged 18-85 years with symptoms of sciatica lasting more than 6 weeks * shorter duration in cases where symptoms significantly impair normal functioning or in cases of muscle strength deficits * symptoms correlate with mri findings of lumbar spine pathology, showing the presence of intervertebral disc herniation (protrusion, extrusion, or sequestration) causing nerve root compression in the lumbar spine. exclusion criteria: * previous lumbar spine surgery in the lumbar-sacral region * mri findings showing degenerative or stenotic spinal canal changes * multi-level pathology where identification of the pain source is not possible * pregnancy
a prospective, randomized clinical study on the effects of casein phosphopeptide-amorphous calcium phosphate (cpp-acp) paste on plaque, gingivitis and white spot lesions in orthodontic patients - part 2

Conditions: Early Caries Lesions

Summary: influence of cpp-acp paste and elmex medical gel on the prevention of white spot lesions in orthodontic patients during fixed appliances.


Eligibility criteria:
inclusion criteria: * no white spot lesion at the time of placement of fixed appliances exclusion criteria: * white spots already present before start orthodontic treatment
navitian pmcf study ( repic04c )

Conditions: Coronary Artery Disease (CAD); Ischemic Heart Disease

Summary: multicenter, prospective, non-randomized, post-market clinical follow-up (pmcf) study to confirm and support the clinical safety and performance of navitian to meet eu medical device regulation (mdr) requirements in all the consecutive patients treated with navitian.

the objective of this multicenter, prospective, non-randomized, post-market clinical follow-up (pmcf) study is to confirm and support the clinical safety and performance of the navitian in a non-selected, real world population under daily clinical practice when used as intended by the manufacturer to meet eu medical device regulation requirements for post-market clinical follow-up.

Eligibility criteria:
inclusion criteria: * patient treated with navitian according to routine hospital practice and following instructions for use * informed consent signed exclusion criteria: * not meet inclusion criteria

Keywords: mdr (medical device regulations) pmcf (post-market clinical follow-up) coronary microcatheter
refinement and assessment of new magnetic resonance imaging technologies for neurological exams

Conditions: Nervous System Diseases

Summary: this study is being done to assess new magnetic resonance imaging (mri) technologies such as new hardware or software designed to improve mri examinations of the brain, spine head and neck regions.

this study is being done to assess new magnetic resonance imaging (mri) technologies such as new hardware or software designed to improve mri examinations of the brain, spine, and head \& neck regions. software and hardware are constantly being improved, new machines replace old machines, software is updated and improved as are the devices used to produce better mri images.

Eligibility criteria:
inclusion criteria: * if you are a male or a non-pregnant female patient * normal volunteer * presenting to mri for a clinically-ordered neurological or head and neck mri exam exclusion criteria: * patients, who have electrically, magnetically or mechanically activated implants such as heart pacemaker, magnetic surgical clips, prostheses or implanted neurological stimulator. * pregnant patients or patients who are lactating. * a patient who is claustrophobic

Keywords: neurological mri
lenvatinib plus pd-1 antibody vs tace for intermediate-stage hcc beyond up-to-seven criteria

Conditions: Hepatocellular Carcinoma

Summary: the purpose of this study is to evaluate the efficacy and safety of lenvatinib combined with pd-1 antibody compared with transarterial chemoembolization (tace) for patients with intermediate-stage hepatocellular carcinoma (hcc) beyond up-to-seven criteria

transarterial chemoembolization (tace) is the most widely used palliative treatment for hepatocellular carcinoma (hcc) patients. while a number of studies demonstrate poor effect of tace for patients with hepatocellular carcinoma staged bclc a/b especially for those with tumor beyond up-to-seven criteria. recently, lenvatinib was proved non-inferior to sorafenib in overall survival in advanced hepatocellular carcinoma, and programmed cell death protein-1 (pd-1) antibody was effective and tolerable in patients with advanced hepatocellular carcinoma. no study has evaluated the efficacy and safety of lenvatinib plus pd-1 antibody in intermediate-stage hcc. thus, the investigators carried out this prospective randomized control to demonstrate the superiority of lenvatinib combined with pd-1 antibody over tace.

Eligibility criteria:
inclusion criteria: * the diagnosis of hcc was based on the diagnostic criteria for hcc used by the european association for the study of the liver (easl) * patients must have at least one tumor lesion that can be accurately measured according to easl criteria. * barcelona clinic liver cancer-stage b * beyond up-to-seven criteria (hepatocellular carcinomas with seven as the sum of the size of the largest tumor \[in cm\] and the number of tumors) * eastern cooperative oncology group performance status of 0 to 1 * no cirrhosis or cirrhotic status of child-pugh class a only * not applicable for transarterial chemoembolization, surgical resection, and local ablative therapy. * the following laboratory parameters: platelet count ≥ 75,000/μl hemoglobin ≥ 8.5 g/dl total bilirubin ≤ 30mmol/ l serum albumin ≥ 30 g/l asl and ast ≤ 5 x upper limit of normal serum creatinine ≤ 1.5 x upper limit of normal inr ≤ 1.5 or pt/aptt within normal limits absolute neutrophil count (anc) \>1,500/mm3 • ability to understand the protocol and to agree to and sign a written informed consent document exclusion criteria: * evidence of hepatic decompensation including ascites, gastrointestinal bleeding or hepatic encephalopathy * known history of hiv * history of organ allograft * known or suspected allergy to the investigational agents or any agent given in association with this trial. * cardiac ventricular arrhythmias requiring anti-arrhythmic therapy * evidence of bleeding diathesis. * patients with clinically significant gastrointestinal bleeding within 30 days prior to study entry. * known central nervous system tumors including metastatic brain disease

Keywords: hepatocellular carcinoma lenvatinib pd-1 antibody tace
a drug interaction study of albiglutide and digoxin

Conditions: Diabetes Mellitus, Type 2

Summary: this phase i, open-label, sequential, single-center study evaluates the pharmacokinetics of digoxin when coadministered with albiglutide in healthy adult subjects.

this phase i, open-label, sequential, single-center study evaluates the pharmacokinetics of digoxin when coadministered with albiglutide in healthy adult subjects. subjects will receive a single dose of digoxin on day 1 followed by 5 weekly subcutaneously injected doses of albiglutide and a second single dose of digoxin on day 38. to determine the plasma pharmacokinetic parameters of digoxin after drug administration alone and after multiple doses of albiglutide, blood samples will be collected after each dose of digoxin.

Eligibility criteria:
inclusion criteria: * healthy volunteers * female subjects must be of nonchildbearing potential * no clinically significant diseases or clinically significant abnormal laboratory values * body mass index (bmi) is \>/=18 kg and ≤30 kg/m2 * a nonsmoker exclusion criteria: * positive test results for hepatitis b, hepatitis c or human immunodeficiency virus * female subject is pregnant or breast-feeding * history of any anaphylactic reaction to any drug * history of significant cardiovascular or pulmonary dysfunction * current or chronic history of liver disease * history of alcohol or substance abuse * history of thyroid disease or dysfunction * history of gastrointestinal surgery or disease * history of pancreatitis * history of cholecystitis or other gallbladder disease * previously received any glp-1 mimetic compound (e.g., exenatide)

Keywords: pharmacokinetics albiglutide healthy volunteer digoxin
effect of transcutaneous auricular vagus nerve stimulation on postoperative myocardial injury in elderly patients undergoing thoracoscopic surgery: a prospective, randomized controlled study

Conditions: Myocardial Injury

Summary: this research group plans to design a prospective, double-blind, randomized controlled study to explore the effect of tavns on hs-ctnt in elderly patients undergoing thoracoscopic surgery, and to evaluate the effect on perioperative myocardial injury and postoperative analgesia during thoracoscopic surgery.

a small number of studies based on transcutaneous auricular vagus nerve stimulation have shown that it has good therapeutic effects on patients with cardiovascular disease, and is simple to operate, with few complications and low risks. however, thoracic surgery is closer to the heart and has a higher incidence of perioperative myocardial injury. , and hs-ctnt has become a biomarker that predicts myocardial injury. this research group plans to design a prospective, double-blind, randomized controlled study to explore the effect of tavns on hs-ctnt in elderly patients undergoing thoracoscopic surgery, and to evaluate the effect on perioperative myocardial injury and postoperative analgesia during thoracoscopic surgery.

Eligibility criteria:
inclusion criteria: 1. aged ≥60 years old 2. inpatients scheduled to undergo elective thoracoscopic lobectomy, segmentectomy, or wedge resection 3. asa score of ⅰ-ⅲ 4. able to communicate with the researcher communicate and cooperate with patients completing assessment scales. exclusion criteria: 1. patients with congenital heart disease, coronary heart disease, myocardial infarction, severe heart block or implanted cardiac pacemaker 2. patients with neurological diseases such as cerebral infarction, cerebral hemorrhage or stroke 3. patients with pain, damage, infection or unhealed ear trauma in the area near the external auricle 4. patients with a history of severe mental illness, abuse of analgesia or addiction to psychiatric drugs 5. patients with severe digestive system diseases 6. patients and their families who refuse surgical anesthesia or are unable to cooperate in completing the questionnaire 7. pregnant women.

Keywords: tavns myocardial injury hs-ctnt thoracoscopic surgery
dose response to topical glyceryl trinitrate in patients with raynaud's phenomenon

Conditions: Raynaud's Phenomenon

Summary: the purpose of this study is to evaluate the blood flow response to topical glyceryl trinitrate when applied to the skin of patient's fingers with raynaud's phenomenon.


Eligibility criteria:
inclusion criteria: * male and female volunteers aged between 18 and 50 inclusive * subject has idiopathic rp (patient may have undifferentiated connective tissue disease with positive ana) diagnosed for more than two (2) years * if a female, subject must be non-pregnant and non-lactating * the subject has provided written informed consent prior to admission to this study exclusion criteria: * history of clinically relevant medical illnesses (not considering rp) that in the investigator's opinion may jeopardize subject's safety or interfere with participation in the study, including but not limited to hemoglobinopathy, hemophilia, clinically significant retinal abnormalities, unstable hypertension, liver diseases, chronic pulmonary diseases, significant cardiovascular diseases, diabetes, thyroid diseases, gout, psychiatric or psychological disorders, cns trauma or active seizure disorders, allergic or immunologically mediated disorders * history in the past five (5) years of drug or alcohol abuse * history in the past five (5) years of vascular migraine or other chronic severe headache * history in the past five (5) years of autonomic neuropathy or postural hypotension * unwilling or unable to comply with the restrictions outlined in the protocol * current use of smoking cessation treatment, including nicotine patches * history of drug allergies, anaphylaxis or laryngeal oedema, including allergy to gtn, propylene/ethylene glycol or common moisturizing creams * use of any nitrate medication or any phosphodiesterase inhibitor within three (3) days prior to or intended use one (1) day following each dosing with study drug * currently treated for hypertension * currently receiving treatment for prevention and/or treatment of rp * use of any investigational medication within 30 days prior to dosing with study medication or scheduled to receive an investigational drug other than during the course of this study * open skin lesions or pathological condition (including, but not limited to, infection) in the area where the study medication is to be applied * use of topical corticosteroid to the hand or fingers within 10 days of treatment with study drug * withdrawal of consent at any time during the study * any condition, which compromises ability to give informed consent or to communicate with the investigator as required for the completion of this study * previously enrolled in the study

Keywords: raynaud's syndrome raynaud's disease rp
positron emission tomography(pet) in lymphoma assessment

Conditions: Hodgkin's Lymphoma; Non Hodgkin's Lymphoma

Summary: this study examines the role of a diagnostic test called positron emission tomography (pet) scanning in patients with malignant lymphoma. the primary goal of this study is to find out how well pet scanning can detect malignant (cancerous) lymphoma, and how often this extra information will result in a change of stage of disease, or will result in a change in treatment management plans of patients with lymphoma.

it is currently unknown whether modifying treatment based on fdg-pet results is appropriate. however, clinicians are increasingly using the fdg-pet result, where obtained, in deciding management. consequently, it would be premature to mandate pet-based treatment modifications in this protocol. patients will be treated with existing protocols at the discretion of their treating oncologists, based on available information. oncologists will be surveyed as to whether fdg-pet scan results could have (or affect patient management, and the intervention will be recorded).

Eligibility criteria:
group a: newly diagnosed inclusion criteria: * patients \> 18 years of age. * confirmed diagnosis of hl or nhl (any histology). * any ann arbor stage. * pre-treatment staging including ct of head and neck, chest, abdomen and pelvis, where there is a minimum one equivocal finding on the scan, affecting the assignment of stage or ipi factor (i.e. stage iii/iv vs. stage i/ii, or a question of extranodal involvement by disease). group b: response assessment inclusion criteria: * patients \> 18 years of age. * confirmed diagnosis of hl or nhl (any histology). * any ann arbor stage. * pre-treatment staging including ct neck, chest, abdomen and pelvis. if alternate assessment of the neck done by clinical palpitation, ultrasound, or mri is negative, ct neck is not mandatory. * post-treatment staging including ct of head and neck, chest, abdomen and pelvis, at 1 - 6 weeks post-therapy. * treated with anthracycline-based chemotherapy, with or without radiation therapy (based on the stage of the disease). for stage iii/iv patients, pet will be done following completion of primary chemotherapy. for stage i/ii patients, pet will be done after combined modality therapy, or after chemotherapy alone if this was the primary intention of therapy. * patients with residual mass on ct following primary chemotherapy with either "unconfirmed" cr (\>75% decrease in size) or pr (³50% decrease in size), based on international workshop criteria. exclusion criteria: response assessment * none curative treatment intent * after initial therapy the response status is: complete response, stable disease, or progressive disease

Keywords: pet scan and hodgkin's lymphoma pet scan and non hodgkin's lymphoma pet scan
evaluation of cetaphil advanced usage to control light to moderate atopic dermatitis, in attempt to reduce the necessity of topic corticoids application

Conditions: Dermatitis, Atopic

Summary: the main goal of this present study is evaluate the decreasing of necessity of topic corticoids usage to control outbreaks of light to moderate atopic dermatitis by using the correct emollients.


Eligibility criteria:
inclusion criteria: * male or female patients * 2 to 10 years old. * with light to moderate with no signs of acute/ sub-acute eczema or in activity. * subjects can not present inflammatory lesions, erythema, edema, eschar, excoriation and lichens. * subjects can present light to moderate dryness. exclusion criteria: * subjects presenting any serious systemic disease * subjects with medical history regarding serious asthma * subjects with known or suspected allergy to one of the investigational products * subjects with acute atopic eczema or in activity, needing systemic antibiotics * subjects with signs of active infections on skin * subjects whose parents or legal guardian seem to have difficulty in understand the informed consent form (icf) * female subjects who are not in pre-menarche period. * subjects who need topic corticoids or any other medication that can interfere on atopic dermatitis during the study. * patient with a wash-out period for treatment less than: * injectable corticoids: 60 days * systemic corticoids: 15 days * topic corticoids: 8 days * topic immunomodulator: 8 days * antihistaminic : 48 hours

Keywords: dermatitis, atopic corticoids, topic corticosteroids
neoadjuvant chemotherapy + surgery versus surgery in figo ib2 and iia2 cervical cancer

Conditions: PFS; OS; Quality of Life

Summary: to clarify the potential benefits of nact before radical surgery(rs), we perform a phase iii, randomised controlled trial to compare nact plus rs with rs alone in patients with stages ib2 and iia2 cervical cancer.

patients with international federation of gynecology and obstetrics (figo) stage ib2 and iia2 cervical cancer are eligible for our study. they will receive paclitaxel + cisplatin(tp)/carboplatin(tc) regimen neoadjuvant chemotherapy (nact) 3 cycles followed by radical surgery (rs) (type iii to v radical hysterectomy plus systematic pelvic lymphadenectomy) (arm a) or directly radical surgery (arm b). postoperative pelvic radiotherapy will be started within 6 weeks after surgery if the patients have pelvic lymph node metastasis, parametrial involvement, deep stromal invasion or positive margin. extended-field external beam therapy, delivering a dose of 4500cgy by a four-field technique, will be administered to patients with positive para-aortic nodes. high-dose rate brachytherapy will be delivered to the vaginal stump if patients have positive surgical margins. the primary end point is 2-years progression-free survival, the secondary end points is overall survival , rate of response to tp or tc regimen chemotherapy and the quality of life.

Eligibility criteria:
inclusion criteria: * patients with newly histologically confirmed cervical carcinoma; * histopathology squamaous carcinoma, adenocarcinoma or adeno-squamous carcinoma; * original clinical stage must be ib2 or iia2 （figo); * age between 18-65; * patients must give signed informed consent; * p.s status: 0-1; * estimated survival time \> 3 months; exclusion criteria: * the presence of uncontrolled life-threatening illness; * receiving other ways of anti-cancer therapy; * investigator consider the patients can't finish the whole study; * with normal liver function test (alt、ast\>2.5×uln); * with normal renal function test (creatinine\>1.5×uln); * wbc\<4,000/mm3 or plt\<100,000/mm; * accompany with other malignancy.

Keywords: neoadjuvant chemotherapy radical surgery cervical carcinoma
ziprasidone vs standard therapy for agitated patients in the ed

Conditions: Psychosis; Agitation; Delirium

Summary: the primary objective is to determine if ziprasidone is superior to standard therapies in the emergency department treatment of the acutely agitated patient. the primary outcome will be the length of time taken until the patient is ready to be evaluated by the psychiatric service, or until a disposition is made.


Eligibility criteria:
inclusion criteria: * acutely agitated * requires chemical sedation exclusion criteria: * physician preference for a specific chemical sedative * known allergy to any study medications

Keywords: psychosis agitation delirium
golf and diabetes.

Conditions: Type2 Diabetes

Summary: this a randomised, single-blinded, controlled study that investigate if a free golf training programme will increase the physical activity of type 2 diabetes patients.


Eligibility criteria:
inclusion criteria: * patients with type 2-diabetes * physical activity less than 8000 steps per day * age \> 18 years exclusion criteria: * pregnancy * conditions that makes patients unfit for participation in golf